Thermage Face Tip 3.0, REF/UDI: TTNS3,00C3-400/UDI (01)000850608002377; REF TTNS3.00C3-600/UDI (01)000850608002384; REF TTNS3.00C3-900; UDI (01)000850608002391 Used in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

Complaints of sparking of the tips of the electrosurgical device used in RF surgical procedures. The use of the affected treatment tips could contribute to potential skin burns.

On 12/30/2019, the firm sent an "URGENT VOLUNTARY MEDICAL DEVICE RECALL" to customers via registered mail to inform them that they have become aware that there is a potential problem related to their device that may result in patient burns. This recall affects 20 lots manufactured and distributed between 08/14/2019 and 12/12/2019. The firm is instructing the customers to: 1. Review their inventory for all devices impacted by this voluntary recall and remove them from the inventory. 2. The manufacturer/ recalling firm is asking their customers to contact Customer Service at 1-877-782-2286 option 1 to arrange the return of the impacted devices in the inventory. 3. In addition, the firm is requesting the customers to complete the enclosed Product Recall Acknowledgement Form and return it to the manufacturer via email at [email protected] or fax at 1-800-685-6430 within 5 days. Solta Customer Service has followed up with customers via phone call and/or email.